RYZOLT
RYZOLT (tramadol hydrochloride) tablet, extended release
Approved
Approval ID
48850874-2b01-404a-bbd9-eb83b15c69fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2010
Manufacturers
FDA
Stat Rx USA
DUNS: 786036330
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TRAMADOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-255
Application NumberNDA021745
Product Classification
M
Marketing Category
C73594
G
Generic Name
TRAMADOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2010
FDA Product Classification
INGREDIENTS (5)
TRAMADOL HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRAMADOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-244
Application NumberNDA021745
Product Classification
M
Marketing Category
C73594
G
Generic Name
TRAMADOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2010
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TRAMADOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-253
Application NumberNDA021745
Product Classification
M
Marketing Category
C73594
G
Generic Name
TRAMADOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2010
FDA Product Classification
INGREDIENTS (6)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT